To be assured consideration, comments on the IFR must be received no later than 11:59 p.m. Eastern Standard Time on March 19, 2018. To submit comments during the open comment period or browse posted comments, go here: https://www.regulations.gov/document?D=HHS-OPHS-2017-0001-0001.
The 2018 edition of the International Compilation of Human Research Standards has been released and is now available on-line: http://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html . The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 130 countries, as well as standards issued by a number of international and regional organizations.
The updated edition includes hundreds of updates from the previous year. Four new countries are included in the 2018 edition: Algeria, Madagascar, Mali, and Saint Lucia. For the first time, this year’s Compilation includes a section on Social-Behavioral Research.
The listings are organized into nine categories:
1. General Research
2. Drugs and Devices
3. Clinical Trial Registries
4. Research Injury
5. Social-Behavioral Research
6. Privacy/Data Protection
7. Human Biological Materials
8. Genetic Research
9. Embryos, Stem Cells, and Cloning
Most of the listings include a hyperlink that allows the user to directly access the law, regulation, or guideline of interest.
Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually.
Human Research Protection Program Fundamentals
Join OHRP's Listserv
OHRP supports institutions in their efforts to evaluate and improve the quality of their human research protections programs (HRPP). OHRP is actively developing and updating outdated resources to assist institutions to achieve this objective. In addition, OHRP is available for consultation to answer specific questions at OHRP@hhs.gov.
Assurance Training
OHRP is developing updated materials that can be used for basic training of HRPP staff. Until the new materials are ready, you can access the content of the previously available Assurance Training modules here: Assurance Training.
Self-Assessment Tool
Institutions can use the OHRP Self-Assessment Tool to conduct a basic self-evaluation of their HRPPs and identify their strengths and areas for improvement. It can be found at: Self-Assessment Tool
OHRP is developing an updated self-assessment tool and will make it available when it is complete. The list of QA questions in the tool is for institutional self-assessment only. Please do not submit your responses to OHRP for review. OHRP does not collect or assess responses to this online self-assessment tool, and currently does not support any other quality assessment program.
If you have questions about HRPP quality assessment requirements related to NCATS’s SMART IRB Authorization Agreement, please contact the NCATS SMART IRB office directly.
Self-Serve Training by Role
Learning about the HHS regulations and policies for the protection of human subjects in research can be challenging. To help you get started, OHRP has compiled educational resources tailored for the different roles in human subjects research. Also, consider attending an OHRP in-person educational event and joining OHRP’s mailing list for our monthly newsletter.
OHRP is happy to answer questions and provide guidance for institutions with questions about their HRPPs. To contact OHRP with questions, email OHRP@hhs.gov or call OHRP at (240) 453-6900.
OHRP understands that everyone is busy and may not have time for an hour-long video. To meet this need, OHRP created a series of short tutorials (each around 15 minutes long) that focus on specific aspects of HHS human subjects regulations and policy. These mini-tutorials are designed to help human research protections professionals build on their knowledge. OHRP’s materials are intended for public use and distribution, and we invite you to share or link to them from your website.
CITI Program has developed resources to help educate the research community on the revisions to the Common Rule before they take effect in January 2018. Here’s what you need to know:
Download free resources developed by experts and peer reviewed including overviews, handouts, and presentations for use at your organization.
We will continue to add more resources throughout the year so check back often.
You can incorporate these resources into your organization's training.
Final Rule Resources A new resource on Secondary Research with Identifiable Information and Biospecimens, with accompanying overview, handouts, and a presentation is now available on ourFinal Rule Resources page.
CITI Program modules affected by the revisions to the Common Rule will be updated by January 2018. View Final Rule Resources
Other available resources:
Overview of the Final Rule Revisions
New and Revised Definitions
Comprehensive Guide to Informed Consent Changes
Overview of the ICH E6(R2) Integrated Addendum This overview covers the revisions to the International Council for Harmonisation's (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), including a breakdown of changes by section with summaries and analyses. The ICH E6(R2) guideline revisions affect sponsors, researchers, and IRBs. CITI Program GCP modules were revised to reflect the integrated addendum and the mutually recognized training courses were re-attested.
CITI Program has created the resources below to help the research community understand the revisions to the Common Rule issued on 19 January 2017 and set to take effect in January 2018. They were developed with the assistance of expert authors and peer reviewers. We will continue to add resources throughout the year so be sure to check back often. We will also be updating CITI Program courses to reflect the revisions by January 2018. https://about.citiprogram.org/en/final-rule-resources/
Please be advised that the revised Human Subject Payments procedure as well as the new Statement of Human Subject Participation form have been posted to the portal.
The U.S. Department of Health and Human Services' and fifteen other Federal Departments and Agencies’ revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule) are included in today’s edition of the Federal Register. These revisions are an effort to modernize, simplify, and enhance the current system of oversight. The Final Rule and additional related information can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.
These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
Today the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. This guidance finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance. To access the Federal Register notice announcing the availability of the final guidance document go to: https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/pdf/2016-30146.pdf or https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/html/2016-30146.htm To access a copy of the final guidance document go to: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/use-electronic-informed-consent-questions-and-answers/index.html
The 2017 edition of the International Compilation of Human Research Standards is available on-line: http://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 126 countries, as well as standards issued by a number of international and regional organizations.
The updated edition includes hundreds of updates from the previous year. Six new countries are included in the 2017 edition: Benin, Bermuda, Democratic Republic of the Congo, Dominican Republic, Guyana, and Senegal.
The listings are organized into eight categories:
1. General Research
2. Drugs and Devices
3. Clinical Trial Registries
4. Research Injury
5. Privacy/Data Protection
6. Human Biological Materials
7. Genetic Research
8. Embryos, Stem Cells, and Cloning
Many of the listings include a hyperlink that allows the user to directly access the law, regulation, or guideline of interest.
Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually.
Final NIH Policy: The Final NIH Policy establishes the expectation that a single IRB of record will be used in the ethical review of non-exempt human subjects research protocols funded by NIH that are carried out at more than one site in the United States. Emphasis is placed on each site conducting the same protocol. The goal is to enhance and streamline the IRB review process in the context of multi-site research so that the research can proceed effectively and expeditiously as possible, and to eliminate duplicative IRB reviews. The effective date of the policy is May 25, 2017.
Policy on the use of a single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States.
➣COGR's 2011 responseto the Department of Health and Human Services (HHS) and White House Office of Science and Technology Policy (OSTP) advanced notice of proposed rulemaking (ANPRM) on Human Subjects Protections also known as the “Common Rule”.
Notice Number:NOT-OD-16-017 Release Date: October 27, 2015 Related Announcements NOT-OD-16-030 Issued by
National Institutes of Health (NIH)
Purpose:
This Notice is to inform NIH grant applicants and recipients of the significant changes that will be incorporated into the revised FY 2016 NIH Grants Policy Statement (NIHGPS). The Significant Changes document summarizes the notable grants policy changes and clarifications that will be implemented in the FY 2016 NIHGPS. Although we anticipate that the FY 2016 NIHGPS will be available in November, we are making the Significant Changes document immediately available to keep applicants and recipients informed of upcoming policy changes and clarifications. Please note that the policy changes and clarifications included in the Significant Changes document will be effective with the publication of the FY 2016 NIHGPS.
The document may be found at the following location: http://grants.nih.gov/grants/policy/nihgps/Significant_Changes_NIHGPS_Oct2015.pdf
Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval: Updated Notice Notice Number:NOT-OD-15-128 Key Dates
National Institutes of Health (NIH)
Purpose
This updated Notice continues to provide detailed guidance on the types of changes in human subjects research awards that will require prior NIH approval and provides information on the process for submission of such requests. This is a revision of a prior notice and is almost identical to the previous notice (NOT-OD-12-129) with a few edits/additions to the language to further clarify expectations regarding NIH policies for the inclusion of women, minorities, and children that are called out in bold italics below. OSP Webpage Links:
The IRB must determine, to the extent required by 45 CFR 46.116, that adequate provisions are made for soliciting the assent of the children -- when in the judgment of the IRB the children are capable of providing assent -- as well as the permission of the parents (45 CFR 46.408). Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research (45 CFR 46.402(c)).
By regulatory definition, children are “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (45 CFR 46.402(a)). In the United States the legal age of adulthood is a matter of state and local law. This means that who is legally considered a child may vary from state to state; in a large majority of states 18 years of age is the legal age of adulthood, but this is not true in every state, locality, or territory. State law also may address specific circumstances in which a person younger than the age of adulthood is legally authorized to consent to medical procedures: for example, some states allow children younger than the legal age of adulthood to consent to the provision of contraceptive services. Certain states provide a mechanism for the emancipation of minors, through which a child younger than the legal age of adulthood may gain certain civil rights, which might include the legal ability to consent to research participation.
The definition of children also takes into account the particular interventions or interactions involved in the proposed research (e.g., surveys, blood tests). For example, in some places individuals who are 16 years of age may legally consent to certain clinical interventions or interactions. If the involvement of human subjects in a proposed research activity consists of these interventions or interactions, then those individuals may be considered as adults for that purpose. If a proposed activity includes an intervention or interaction for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.
Under 45 CFR 408(b) the IRB may find that the permission of one parent is sufficient for research to be conducted under 45 CFR 46.404 or 45 CFR 46.405. Where research is conducted under 45 CFR 46.406 or 45 CFR 46.407, permission must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
Although the regulations state that children are unable to provide legally effective informed consent to participate in research, some might be able to give their assent. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent (45 CFR 46.402(b)).
If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted regarding assent, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under certain circumstances in accord with 45 CFR 46.116 and 45 CFR 46.408(a).
To be assured consideration, comments on the IFR must be received no later than 11:59 p.m. Eastern Standard Time on March 19, 2018. To submit comments during the open comment period or browse posted comments, go here: https://www.regulations.gov/document?D=HHS-OPHS-2017-0001-0001.
The 2018 edition of the International Compilation of Human Research Standards has been released and is now available on-line: http://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html . The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 130 countries, as well as standards issued by a number of international and regional organizations.
The updated edition includes hundreds of updates from the previous year. Four new countries are included in the 2018 edition: Algeria, Madagascar, Mali, and Saint Lucia. For the first time, this year’s Compilation includes a section on Social-Behavioral Research.
The listings are organized into nine categories:
1. General Research
2. Drugs and Devices
3. Clinical Trial Registries
4. Research Injury
5. Social-Behavioral Research
6. Privacy/Data Protection
7. Human Biological Materials
8. Genetic Research
9. Embryos, Stem Cells, and Cloning
Most of the listings include a hyperlink that allows the user to directly access the law, regulation, or guideline of interest.
Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually.
Human Research Protection Program Fundamentals
Join OHRP's ListservOHRP supports institutions in their efforts to evaluate and improve the quality of their human research protections programs (HRPP). OHRP is actively developing and updating outdated resources to assist institutions to achieve this objective. In addition, OHRP is available for consultation to answer specific questions at OHRP@hhs.gov.
Assurance Training
OHRP is developing updated materials that can be used for basic training of HRPP staff. Until the new materials are ready, you can access the content of the previously available Assurance Training modules here: Assurance Training.Self-Assessment Tool
Institutions can use the OHRP Self-Assessment Tool to conduct a basic self-evaluation of their HRPPs and identify their strengths and areas for improvement. It can be found at: Self-Assessment ToolOHRP is developing an updated self-assessment tool and will make it available when it is complete. The list of QA questions in the tool is for institutional self-assessment only. Please do not submit your responses to OHRP for review. OHRP does not collect or assess responses to this online self-assessment tool, and currently does not support any other quality assessment program.
If you have questions about HRPP quality assessment requirements related to NCATS’s SMART IRB Authorization Agreement, please contact the NCATS SMART IRB office directly.
Self-Serve Training by Role
Learning about the HHS regulations and policies for the protection of human subjects in research can be challenging. To help you get started, OHRP has compiled educational resources tailored for the different roles in human subjects research. Also, consider attending an OHRP in-person educational event and joining OHRP’s mailing list for our monthly newsletter.Educational Resources for IRB Members
Educational Resources for IRB Administrators and Staff
Educational Resources for Investigators
OHRP Consultation
OHRP is happy to answer questions and provide guidance for institutions with questions about their HRPPs. To contact OHRP with questions, email OHRP@hhs.gov or call OHRP at (240) 453-6900.
Additional Educational Resources
OHRP offers additional educational modules at our Online Education page. These educational modules provide information and answer common questions about the HHS regulations to protect human subjects in research and IRB review of human subjects research.If you have questions about OHRP's educational resources, contact OHRP at OHRP-EDU@hhs.gov or call OHRP at (240) 453-6900.
Watch educational videosThe videos below cover material that is particularly relevant to IRB administrators and staff•Membership Requirements for Institutional Review Board
•Quorum Requirements for Convened IRB Review Meeting
•OHRP Reporting Requirements
•Back to Basics: Does My Project Fall Within the Scope of the Regulations?
• When the Assurance Comes A Knockin': OHRP's FWA and IRB Registration Process
•When the Feds Come A Knockin': How to Prepare for an OHRP Compliance Evaluation of Your Program
• IRB Records, Parts I and II
More videos can be found on OHRP’s Online Education page: https://www.hhs.gov/ohrp/education-and-outreach/online-education/index.html
Find OHRP guidance
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html
Review commonly used guidance for IRB administrators and staff
•Determining When Institutions are Engaged in Research (2009):
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/determining-when-institutions-are-engaged-in-research/index.html
•Extending an FWA to Cover Collaborating Investigators (2005):
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual-investigator-agreement/index.html
•Guidance on Reporting Incidents to OHRP (2011):
https://www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting-incident/index.html
•Compliance Oversight Procedures for Evaluating Institutions (2009):
https://www.hhs.gov/ohrp/compliance-and-reporting/evaluating-institutions/index.html
•Assurance Process FAQs:https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/assurance-process/index.htm
•Written Institutional Review Board Procedures: OHRP Guidance (2011):
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-written-irb-procedures/index.html
•Human Subject Regulations Decision Charts:https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.htm
•Exempt Research Determination FAQs:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/exempt-research-determination/index.html
Mini-Tutorials
OHRP understands that everyone is busy and may not have time for an hour-long video. To meet this need, OHRP created a series of short tutorials (each around 15 minutes long) that focus on specific aspects of HHS human subjects regulations and policy. These mini-tutorials are designed to help human research protections professionals build on their knowledge. OHRP’s materials are intended for public use and distribution, and we invite you to share or link to them from your website.IRB Review Criteria (12:43)
Quorum and Voting in IRB Meetings (22:16)
Membership Requirements for Institutional Review Boards (IRB) (13:01)
Prisoner Research Series
OHRP Reporting Requirements
CITI Program has developed resources to help educate the research community on the revisions to the Common Rule before they take effect in January 2018. Here’s what you need to know:
- Download free resources developed by experts and peer reviewed including overviews, handouts, and presentations for use at your organization.
- We will continue to add more resources throughout the year so check back often.
- You can incorporate these resources into your organization's training.
We will also update relevant CITI Program modules by January 2018. It’s all part of our commitment to supporting the research community in any way possible.http://citiprogram.cmail19.com/t/i-l-ozihdk-druduukyy-y/
Final Rule Resources
A new resource on Secondary Research with Identifiable Information and Biospecimens, with accompanying overview, handouts, and a presentation is now available on our Final Rule Resources page.
CITI Program modules affected by the revisions to the Common Rule will be updated by January 2018.
View Final Rule Resources
Other available resources:
Overview of the ICH E6(R2) Integrated Addendum
This overview covers the revisions to the International Council for Harmonisation's (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), including a breakdown of changes by section with summaries and analyses. The ICH E6(R2) guideline revisions affect sponsors, researchers, and IRBs.
CITI Program GCP modules were revised to reflect the integrated addendum and the mutually recognized training courses were re-attested.
Download Now
CITI Program has created the resources below to help the research community understand the revisions to the Common Rule issued on 19 January 2017 and set to take effect in January 2018. They were developed with the assistance of expert authors and peer reviewers. We will continue to add resources throughout the year so be sure to check back often. We will also be updating CITI Program courses to reflect the revisions by January 2018.
https://about.citiprogram.org/en/final-rule-resources/
Please be advised that the revised Human Subject Payments procedure as well as the new Statement of Human Subject Participation form have been posted to the portal.
The U.S. Department of Health and Human Services' and fifteen other Federal Departments and Agencies’ revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule) are included in today’s edition of the Federal Register. These revisions are an effort to modernize, simplify, and enhance the current system of oversight. The Final Rule and additional related information can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.
These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
The final rule is being put on public display on January 18, 2017, by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects. It is expected that the final rule will be published in the Federal Register on January 19, 2017.
HHS released a Press Release about the final rule that can be accessed at: https://www.hhs.gov/about/news/2017/01/18/final-rule-enhances-protections-research-participants-modernizes-oversight-system.html.
U.S. Department of Health and Human Services
Today the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. This guidance finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance. To access the Federal Register notice announcing the availability of the final guidance document go to: https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/pdf/2016-30146.pdf or https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/html/2016-30146.htm To access a copy of the final guidance document go to: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/use-electronic-informed-consent-questions-and-answers/index.html
The State University of New York at Plattsburgh Human Subject Policies
http://www.plattsburgh.edu/offices/admin/sponsoredresearch/policies/humans.php
Human Subject Regulations Decision Charts
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
NPRM Town Hall Meetings
Videos on recent changes pertaining to IRBs.https://www.youtube.com/playlist?list=PLrl7E8KABz1HThmKd6A5viE3c8aeH7-uQ
NPRM for Revisions to the Common Rule
http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.htmlRe. Parental permission (section H):
http://www.hhs.gov/ohrp/policy/faq/children-research/both-parents-provide-permission.html
The 2017 edition of the International Compilation of Human Research Standards is available on-line: http://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 126 countries, as well as standards issued by a number of international and regional organizations.
The updated edition includes hundreds of updates from the previous year. Six new countries are included in the 2017 edition: Benin, Bermuda, Democratic Republic of the Congo, Dominican Republic, Guyana, and Senegal.
The listings are organized into eight categories:
1. General Research
2. Drugs and Devices
3. Clinical Trial Registries
4. Research Injury
5. Privacy/Data Protection
6. Human Biological Materials
7. Genetic Research
8. Embryos, Stem Cells, and Cloning
Many of the listings include a hyperlink that allows the user to directly access the law, regulation, or guideline of interest.
Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually.
http://www.cogr.edu/Human-Subjects-and-Animal-Research
Final NIH Policy: The Final NIH Policy establishes the expectation that a single IRB of record will be used in the ethical review of non-exempt human subjects research protocols funded by NIH that are carried out at more than one site in the United States. Emphasis is placed on each site conducting the same protocol. The goal is to enhance and streamline the IRB review process in the context of multi-site research so that the research can proceed effectively and expeditiously as possible, and to eliminate duplicative IRB reviews. The effective date of the policy is May 25, 2017.
Policy on the use of a single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States.
**Federal**
Significant Changes: FY 2016 NIH Grants Policy Statement
Analysis of Common Rule Comments
In January 2016, COGR staff and university and association volunteers began an analysis of the 2,186 comments submitted to regulations.gov in response to the Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects (Common Rule). Respondents were grouped by category (e.g., patient, public, university, researcher, etc.) and comments on major provisions coded. A summary and table of the findings, as well as summaries for each respondent category, can be found below. For more information on this analysis, please contact Lisa Nichols, Director for Research & Regulatory Reform.
Analysis of Public Comments on the Common Rule NPRM
Data Tables:
Table 1- Responses by Respondent Category
Table 2- Results
Table 3- Advocacy Groups by Subcategory
Common Rule NPRM Comment Summaries by Respondent Category:
Patients and Patient Representatives
General Public
Academic Researchers
Universities/Medical Centers/IRBs
Industry/Pharma/Trade Groups
Tribal Nations
Advisory and Related Groups
Independent IRBs
Departments of Health, Health Officials, Municipal Governments and Epidemiologists
Biorepositories, Affiliated Organizations and Consultants
Disease Registries
Professional Societies and Associations
Advocacy Groups
Press Release
May 9, 2016- COGR/APLU/AAU Issue Joint Press Release
Common Rule Notices of Proposed Rulemaking
2011 Common Rule ANPRM
- ➣COGR's 2011 responseto the Department of Health and Human Services (HHS) and White House Office of Science and Technology Policy (OSTP) advanced notice of proposed rulemaking (ANPRM) on Human Subjects Protections also known as the “Common Rule”.
2015 Common Rule NPRMNotice Number: NOT-OD-16-017
Release Date: October 27, 2015
Related Announcements
NOT-OD-16-030
Issued by
National Institutes of Health (NIH)
Purpose:
This Notice is to inform NIH grant applicants and recipients of the significant changes that will be incorporated into the revised FY 2016 NIH Grants Policy Statement (NIHGPS). The Significant Changes document summarizes the notable grants policy changes and clarifications that will be implemented in the FY 2016 NIHGPS. Although we anticipate that the FY 2016 NIHGPS will be available in November, we are making the Significant Changes document immediately available to keep applicants and recipients informed of upcoming policy changes and clarifications. Please note that the policy changes and clarifications included in the Significant Changes document will be effective with the publication of the FY 2016 NIHGPS.
The document may be found at the following location: http://grants.nih.gov/grants/policy/nihgps/Significant_Changes_NIHGPS_Oct2015.pdf
Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval: Updated Notice
Notice Number: NOT-OD-15-128
Key Dates
Release Date: July 30, 2015
Related Announcements
NOT-OD-15-129
NOT-OD-12-130
NOT-OD-12-129
Issued by
National Institutes of Health (NIH)
Purpose
This updated Notice continues to provide detailed guidance on the types of changes in human subjects research awards that will require prior NIH approval and provides information on the process for submission of such requests. This is a revision of a prior notice and is almost identical to the previous notice (NOT-OD-12-129) with a few edits/additions to the language to further clarify expectations regarding NIH policies for the inclusion of women, minorities, and children that are called out in bold italics below.
OSP Webpage Links:
2016 Edition of the International Compilation of Human Research Standards.
What are the requirements for assent and parental permission in research with children?
The IRB must determine, to the extent required by 45 CFR 46.116, that adequate provisions are made for soliciting the assent of the children -- when in the judgment of the IRB the children are capable of providing assent -- as well as the permission of the parents (45 CFR 46.408). Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research (45 CFR 46.402(c)).By regulatory definition, children are “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (45 CFR 46.402(a)). In the United States the legal age of adulthood is a matter of state and local law. This means that who is legally considered a child may vary from state to state; in a large majority of states 18 years of age is the legal age of adulthood, but this is not true in every state, locality, or territory. State law also may address specific circumstances in which a person younger than the age of adulthood is legally authorized to consent to medical procedures: for example, some states allow children younger than the legal age of adulthood to consent to the provision of contraceptive services. Certain states provide a mechanism for the emancipation of minors, through which a child younger than the legal age of adulthood may gain certain civil rights, which might include the legal ability to consent to research participation.
The definition of children also takes into account the particular interventions or interactions involved in the proposed research (e.g., surveys, blood tests). For example, in some places individuals who are 16 years of age may legally consent to certain clinical interventions or interactions. If the involvement of human subjects in a proposed research activity consists of these interventions or interactions, then those individuals may be considered as adults for that purpose. If a proposed activity includes an intervention or interaction for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.
Under 45 CFR 408(b) the IRB may find that the permission of one parent is sufficient for research to be conducted under 45 CFR 46.404 or 45 CFR 46.405. Where research is conducted under 45 CFR 46.406 or 45 CFR 46.407, permission must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
Although the regulations state that children are unable to provide legally effective informed consent to participate in research, some might be able to give their assent. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent (45 CFR 46.402(b)).
If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted regarding assent, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under certain circumstances in accord with 45 CFR 46.116 and 45 CFR 46.408(a).
Category
Informed ConsentHHS Site:
http://www.hhs.gov/ohrp/
Renewal Site:
http://ohrp.cit.nih.gov/efile/IrbRnwStart.aspx
Primer HS and IACUC Site:
http://www.primr.org/
Newsletter example:
http://www.magnetmail.net/actions/email_web_version.cfm?recipient_id=1500629614&message_id=6568307&user_id=PRIMR&group_id=1404306&jobid=21631921
dont-blame-facebook-for-screwing-with-your-mood-blame-academia
http://www.washingtonpost.com/posteverything/wp/2014/07/03/dont-blame-facebook-for-screwing-with-your-mood-blame-academia/?tid=recommended_strip_2
HS Policy Doc Address:
https://docs.google.com/a/fredonia.edu/document/d/105AKgLYBfCgpT1Pe9BLi7ORtbUb1BAy9LaHU7NqyuFs/edit?disco=AAAAAHy2AsM
Blanket Exemption of Class Research Fredonia.docx
- Details
- Download
- 42 KB
CITI HS Training:https://www.citiprogram.org
The //Belmont Report// | HHS.gov
www.hhs.gov › ASH › OHRP Home › RegulationsThe Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an ...
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
//Belmont Report// - Wikipedia, the free encyclopedia
en.wikipedia.org/wiki/Belmont_ReportThe Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is ... http://en.wikipedia.org/wiki/Belmont_Report
History - Summary - The Belmont Report Today - Critique of the Report
Office for Human Research Protections (OHRP) - Categories of Research:
http://www.hhs.gov/ohrp/policy/expedited98.htmlPolicy & Guidance:
http://www.hhs.gov/ohrp/policy/index.html#continuinghttp://www.hhs.gov/ohrp/policy/irbgd107.html